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Desflurane-induced Myocardial Protection

NCT ID: NCT02019797

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.

Detailed Description

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Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass are included in the study. Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a TIVA during the surgery. All patients receive a continuous infusion of remifentanil. Biomarker of myocardial damage troponin I is examined at 4 points; T1: after the induction of anesthesia, T2: arrival at ICU, T3: 12 hours after the ICU arrival, T4: 24 hours after the ICU arrival, T5: third post operative day (3POD).

Conditions

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Aortic Valve Stenosis

Keywords

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aortic valve replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Desflurane

Desflurane inhalation at 1-2 MAC during surgery.

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery.

Propofol

5-8 mg/kg/hr infusion during surgery.

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery.

Interventions

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Desflurane

Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery.

Intervention Type DRUG

Other Intervention Names

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SUPRANE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.

Exclusion Criteria

* Patients younger than 20 years old.
* Recent myocardial infarction (within 1 year).
* Renal dysfunction (GFR less than 50ml/min).
* Known allergy to study drugs including propofol.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Nobuyuki Katori

OTHER

Sponsor Role lead

Responsible Party

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Nobuyuki Katori

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Makoto Suematsu, M.D., Ph.D

Role: STUDY_CHAIR

Keio University

Locations

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Keio University Hospital

Tokyo, , Japan

Site Status

Countries

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Japan

Central Contacts

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Nobuyuki Katori, M.D.

Role: CONTACT

Phone: 81-3-3353-1211

Email: [email protected]

Hiroshi Morisaki, M.D.

Role: CONTACT

Phone: 81-3-3353-1211

Email: [email protected]

Facility Contacts

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Nobuyuki Katori, M.D.

Role: primary

Hiroshi Morisaki, M.D.

Role: backup

Other Identifiers

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Desflurane

Identifier Type: -

Identifier Source: org_study_id